Vigabatrin REMS Program

The U.S. Food and Drug Administration (FDA) has approved a single shared system Risk Evaluation and Mitigation Strategy (REMS) for all vigabatrin products called the Vigabatrin REMS Program. It is required by the FDA to ensure informed risk-benefit decisions before initiating treatment and to ensure appropriate use of vigabatrin while patients are treated.

Visit the Vigabatrin REMS website for instructions and the FDA-mandated REMS forms.

What is VIGADRONE™?

VIGADRONE™ (vigabatrin) for Oral Solution is a prescription medicine used for the treatment of:

Infantile Spasms (IS) in babies 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking vigabatrin are more important than the possible risk of vision loss.

Refractory Complex Partial Seizures (CPS) used along with other treatments to treat adults and children 10 years and older if:

The CPS does not respond well enough to several other treatments, and

You and your healthcare provider decide the possible benefit of taking vigabatrin is more important than the risk of vision loss.

IMPORTANT SAFETY INFORMATION

WARNING: PERMANENT VISION LOSS

See Medication Guide and full Prescribing Information for complete information.

All people who take VIGADRONE:

You are at risk for permanent vision loss with any amount of vigabatrin.

Your risk of vision loss may be higher the more vigabatrin you take daily and the longer you take it.

It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting vigabatrin or any time during treatment. It may even happen after treatment has stopped.

WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE?

Because VIGADRONE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you.

VIGADRONE can damage the vision of anyone who takes it. People who take VIGADRONE do not lose all of their vision, but some people can have severe loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.

Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred.

Regular vision testing is recommended. It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting VIGADRONE, and at least every 3 months during treatment until VIGADRONE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGADRONE is stopped. It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed.

Vision tests cannot prevent the vision damage that can happen with VIGADRONE, but they do allow VIGADRONE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in babies, until it is severe.

If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing VIGADRONE, but will not be able to watch for any vision loss.

Magnetic resonance imaging (MRI) changes in babies with IS. Brain pictures taken by MRI show changes in some babies after they are given VIGADRONE. It is not known if these changes are harmful.

Risk of suicidal thoughts or actions. Like other antiepileptic drugs, VIGADRONE may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you.

Do not stop VIGADRONE without first talking to a healthcare provider. Stopping VIGADRONE suddenly can cause seizures that will not stop.

VIGADRONE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because VIGADRONE causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. VIGADRONE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse.

If you are breastfeeding or plan to breastfeed, VIGADRONE can pass into breast milk and may harm your baby.

If you are pregnant or plan to become pregnant, it is not known if VIGADRONE will harm your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE while you are pregnant.

The most common side effects of VIGADRONE in adults include: problems walking or feeling uncoordinated, feeling dizzy, shaking (tremor), joint pain, memory problems and not thinking clearly, and eye problems like blurry vision, double vision, and eye movements that cannot be controlled.

The most common side effects of VIGADRONE in children 10 to 16 years of age include weight gain, upper respiratory tract infection, tiredness, and aggression. Also expect side effects like those seen in adults.

The most common side effects of VIGADRONE in babies include: sleepiness—some babies may have a harder time suckling and feeding or may be irritable, swelling in the bronchial tubes (bronchitis), ear infection, and irritability.

Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away.

WHAT IS VIGADRONE?

VIGADRONE (vigabatrin) for Oral Solution is a prescription medicine used for the treatment of:

Infantile Spasms (IS) in babies 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking vigabatrin are more important than the possible risk of vision loss.

Refractory Complex Partial Seizures (CPS) used along with other treatments to treat adults and children 10 years and older if: (1) The CPS does not respond well enough to several other treatments, and (2) You and your healthcare provider decide the possible benefit of taking vigabatrin is more important than the risk of vision loss.

VIGADRONE should not be the first medicine used to treat CPS.

This is the most important information to know about VIGADRONE, but not all of the possible side effects of VIGADRONE. For more information, ask your healthcare provider or pharmacist, or please see VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit www.VIGADRONE.com, www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088.

VIGADRONE is a trademark of Upsher-Smith Laboratories, LLC.

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